To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c

Diabetes Mellitus, Type 2 Clinical Trial

— LEAD-3  

Official title:

Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00294723
• Other study ID #: NN2211-1573
• Status: Terminated
• Phase: Phase 3
• First received: February 20, 2006
• Last updated: June 25, 2014
• Start date: February 2006
• Est. completion date: March 2010

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health RisksUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in North America (the United States of America (USA) and Mexico).

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).

Other known NCT identifiers

• NCT00853359

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 746
• Est. completion date: March 2010
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months

• Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive

• OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive

• Body Mass Index (BMI) less than or equal to 45 kg/m^2

Exclusion Criteria:

• Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness

• Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)

• Any serious medical condition

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
1.8 mg for s.c. (under the skin) injection
• glimepiride
8 mg capsule
• liraglutide
1.2 mg for s.c. (under the skin) injection
• glimepiride
8 mg capsule
• placebo
Glimepiride placebo, 8mg capsule
• placebo
Liraglutide placebo, 200 mcl
• placebo
Liraglutide placebo, 300 mcl

Locations

Country	Name	City	State
Puerto Rico	Novo Nordisk Clinical Trial Call Center	Rio Piedras
United States	Novo Nordisk Clinical Trial Call Center	Albany	New York
United States	Novo Nordisk Clinical Trial Call Center	Arlington	Texas
United States	Novo Nordisk Clinical Trial Call Center	Asheville	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Athens	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Baltimore	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Bend	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Berlin	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Blue Ridge	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Butte	Montana
United States	Novo Nordisk Clinical Trial Call Center	Charlotte	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Chattanooga	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Chesterfield	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Cleveland	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Columbus	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Corpus Christi	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dayton	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Daytona Beach	Florida
United States	Novo Nordisk Clinical Trial Call Center	Delray Beach	Florida
United States	Novo Nordisk Clinical Trial Call Center	Des Moines	Iowa
United States	Novo Nordisk Clinical Trial Call Center	Durham	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	East Providence	Rhode Island
United States	Novo Nordisk Clinical Trial Call Center	Edmonds	Washington
United States	Novo Nordisk Clinical Trial Call Center	Escondido	California
United States	Novo Nordisk Clinical Trial Call Center	Eugene	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Fullerton	California
United States	Novo Nordisk Clinical Trial Call Center	Greensboro	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Greer	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Honolulu	Hawaii
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Hyattsville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Indianapolis	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Inglewood	California
United States	Novo Nordisk Clinical Trial Call Center	Jackson	Mississippi
United States	Novo Nordisk Clinical Trial Call Center	Jacksonville	Florida
United States	Novo Nordisk Clinical Trial Call Center	Jacksonville	Florida
United States	Novo Nordisk Clinical Trial Call Center	Lancaster	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Las Vegas	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Lewiston	New York
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Longwood	Florida
United States	Novo Nordisk Clinical Trial Call Center	Marietta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Maywood	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Medford	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Mentor	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Midland	Texas
United States	Novo Nordisk Clinical Trial Call Center	Minneapolis	Minnesota
United States	Novo Nordisk Clinical Trial Call Center	Mission Viejo	California
United States	Novo Nordisk Clinical Trial Call Center	New Orleans	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	New York	New York
United States	Novo Nordisk Clinical Trial Call Center	Norristown	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Northport	New York
United States	Novo Nordisk Clinical Trial Call Center	Ocala	Florida
United States	Novo Nordisk Clinical Trial Call Center	Oklahoma City	Oklahoma
United States	Novo Nordisk Clinical Trial Call Center	Olympia	Washington
United States	Novo Nordisk Clinical Trial Call Center	Omaha	Nebraska
United States	Novo Nordisk Clinical Trial Call Center	Orange	California
United States	Novo Nordisk Clinical Trial Call Center	Philadelphia	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Powder Springs	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Princeton	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Reno	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Renton	Washington
United States	Novo Nordisk Clinical Trial Call Center	Richmond	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Salt Lake City	Utah
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	Santa Barbara	California
United States	Novo Nordisk Clinical Trial Call Center	Shawnee Mission	Kansas
United States	Novo Nordisk Clinical Trial Call Center	Spartanburg	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Spokane	Washington
United States	Novo Nordisk Clinical Trial Call Center	Spring Valley	California
United States	Novo Nordisk Clinical Trial Call Center	St. Cloud	Florida
United States	Novo Nordisk Clinical Trial Call Center	St. Louis	Missouri
United States	Novo Nordisk Clinical Trial Call Center	St. Louis	Missouri
United States	Novo Nordisk Clinical Trial Call Center	St. Paul	Minnesota
United States	Novo Nordisk Clinical Trial Call Center	St. Peters	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Staten Island	New York
United States	Novo Nordisk Clinical Trial Call Center	Syracuse	New York
United States	Novo Nordisk Clinical Trial Call Center	Tacoma	Washington
United States	Novo Nordisk Clinical Trial Call Center	Topeka	Kansas
United States	Novo Nordisk Clinical Trial Call Center	Tucker	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Tulsa	Oklahoma
United States	Novo Nordisk Clinical Trial Call Center	Tupelo	Mississippi
United States	Novo Nordisk Clinical Trial Call Center	Vista	California
United States	Novo Nordisk Clinical Trial Call Center	Walnut Creek	California
United States	Novo Nordisk Clinical Trial Call Center	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52	Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)	week 0, week 52	No
Primary	Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104	Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)	week 0, week 104	No
Primary	Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156	Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks	week 0, week 156	No
Secondary	Change in Body Weight at Week 52	Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)	week 0, week 52	No
Secondary	Change in Body Weight at Week 104	Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)	week 0, week 104	No
Secondary	Change in Body Weight at Week 156	Change in body weight from baseline (week 0) to 156 weeks	week 0, week 156	No
Secondary	Change in Fasting Plasma Glucose at Week 52	Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)	week 0, week 52	No
Secondary	Change in Fasting Plasma Glucose at Week 104	Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)	week 0, week 104	No
Secondary	Change in Fasting Plasma Glucose at Week 156	Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks	week 0, week 156	No
Secondary	Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52	Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.	week 0, week 52	No
Secondary	Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104	Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.	week 0, week 104	No
Secondary	Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156	Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.	week 0, week 156	No
Secondary	Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52	Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.	week 0, week 52	No
Secondary	Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104	Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.	week 0, week 104	No
Secondary	Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156	Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.	week 0, week 156	No
Secondary	Hypoglycaemic Episodes	Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.	weeks 0-104	Yes
Secondary	Hypoglycaemic Episodes	Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.	weeks 104-195	Yes

External Links

•   Clinical Trials at Novo Nordisk